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United States · US · US:42658-010_469b1a08-e725-1e50-e063-6394a90a42b6
Cladribine
Orange BookUNIISPLATC L01BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHisun Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeL01BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142658010011 mL in 1 VIAL, SINGLE-DOSE (42658-010-01)
Annotations
UNII (FDA Substance ID)
47M74X9YT5
CLADRIBINE
RxCUI 44157
Orange Book
A210856
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "47M74X9YT5",
"rxcui": "44157",
"inchikey": "PTOAARAWEBMLNO-KVQBGUIXSA-N",
"display_name": "CLADRIBINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"e0b363cb-db83-44d6-89d0-1f7176be7459": {
"match": "brand_token",
"title": "CLADRIBINE TABLET [SANDOZ INC.]",
"spl_version": "1",
"published_date": "2026-04-24"
}
},
"productid": "42658-010_469b1a08-e725-1e50-e063-6394a90a42b6",
"productndc": "42658-010",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "210856",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Nov 25, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLADRIBINE",
"proprietary_name": "Cladribine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA210856",
"marketing_category": "ANDA",
"nonproprietary_name": "Cladribine",
"start_marketing_date": "20200518",
"active_numerator_strength": "1"
}Related drugs
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